S Witte1, H-P Knaebel, P Kienle, C M Seiler. 1. Studienzentrum der Deutschen Gesellschaft für Chirurgie, Abteilung für Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik, Universitätsklinikum Heidelberg, Heidelberg.
Abstract
BACKGROUND: The Study Centre of the German Surgical Society (SDGC) designs, conducts, and analyses multicentre randomised controlled surgical trials. The aim of this paper is to present the decision-making process and responsibilities of the SDGC from submission of a study idea to full protocol development in order to achieve transparency in trial selection. METHODS: The process is divided into four steps. Study ideas can be submitted electronically by members of the German Surgical Society using a form via the homepage of the institution. Firstly, ideas are screened by staff members within 4 weeks for methodological and clinical relevance. Feasible and novel ideas are then converted to trial outlines in cooperation with the submitting surgeon. As a third step, the Steering Committee of the SDGC decides whether to accept the project using a list of defined criteria. Finally, the SDGC draws up a full protocol together with the submitting surgeon. All ideas and decisions are accessible via the SDGC homepage. CONCLUSIONS: The process described should help in the selection of relevant projects, acquisition of grants, and maintenance of transparency in trial selection and the protocol development process.
BACKGROUND: The Study Centre of the German Surgical Society (SDGC) designs, conducts, and analyses multicentre randomised controlled surgical trials. The aim of this paper is to present the decision-making process and responsibilities of the SDGC from submission of a study idea to full protocol development in order to achieve transparency in trial selection. METHODS: The process is divided into four steps. Study ideas can be submitted electronically by members of the German Surgical Society using a form via the homepage of the institution. Firstly, ideas are screened by staff members within 4 weeks for methodological and clinical relevance. Feasible and novel ideas are then converted to trial outlines in cooperation with the submitting surgeon. As a third step, the Steering Committee of the SDGC decides whether to accept the project using a list of defined criteria. Finally, the SDGC draws up a full protocol together with the submitting surgeon. All ideas and decisions are accessible via the SDGC homepage. CONCLUSIONS: The process described should help in the selection of relevant projects, acquisition of grants, and maintenance of transparency in trial selection and the protocol development process.
Authors: Hanns-Peter Knaebel; Markus K Diener; Moritz N Wente; Hartwig Bauer; Markus W Büchler; Matthias Rothmund; Christoph M Seiler Journal: Langenbecks Arch Surg Date: 2005-02-22 Impact factor: 3.445
Authors: Hanns-Peter Knaebel; Moritz Koch; Stefan Sauerland; Markus K Diener; Markus W Büchler; Christoph M Seiler Journal: BMC Surg Date: 2005-03-08 Impact factor: 2.102
Authors: Nuh N Rahbari; Markus K Diener; Lars Fischer; Moritz N Wente; Peter Kienle; Markus W Büchler; Christoph M Seiler Journal: Trials Date: 2008-01-24 Impact factor: 2.279